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Covid-19: Gilead withdraws orphan drug designation from potential treatment after criticism

BMJ 2020; 368 doi: https://doi.org/10.1136/bmj.m1259 (Published 26 March 2020) Cite this as: BMJ 2020;368:m1259

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  1. Elisabeth Mahase
  1. The BMJ

The US Food and Drug Administration (FDA) has withdrawn orphan drug designation from a potential covid-19 treatment, after criticism that treating covid-19 as a rare disease was “disingenuous.”

Pharmaceutical company Gilead requested that the FDA withdraw the designation—which was set to give the company a longer exclusivity period (seven years instead of five) and significant tax incentives—just days after it was given.1

Remdesivir, which works to inhibit viral replication, is a drug currently being investigated as a potential treatment for covid-19 through several clinical trials.

Orphan status is a mechanism designed to promote the development …

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